Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BXM · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013215 | MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | 2001-10-16 | 20 | 0 |
| K002677 | NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | 2000-11-13 | 77 | 0 |
| K921498 | VER MED A10011 PNS DUAL ELEMENT ELECTRODE | Vermont Medical, Inc. | 1993-06-09 | 435 | 0 |
| K870662 | MODEL SKCK STERILE KNOB COVER KIT | Life-Tech Intl., Inc. | 1987-10-28 | 251 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda